An academic review answers a research question for publication. A market access literature review answers a decision problem for a payer. That difference reshapes every design choice. The audience is a reimbursement committee or an assessment agency, not a journal editor, so the protocol is written to a defined PICOS frame (population, intervention, comparators, outcomes, and study design) that mirrors the anticipated appraisal scope. Comparators are chosen to reflect the relevant standard of care in each jurisdiction, not merely what has been studied most. Outcomes are prioritised around what drives value, including overall survival, progression-free survival, response rates, adverse events, health-related quality of life, and resource use.
The second difference is cadence. HTA submissions run to fixed windows, so a systematic literature review for HTA is a submission-deadline-driven exercise with a locked protocol, an auditable search, and a reproducible selection trail. The third difference is transparency of judgement. Payers expect to see why every included and excluded study was handled as it was, because their own methods teams will re-run parts of the review. Credible health technology assessment consulting therefore documents search strings, database coverage, screening decisions, and appraisal ratings at a level most academic papers never reach.
If your team needs the underlying methodology explained in depth, our core systematic review methodology service covers protocol registration, screening workflows, and PRISMA reporting that we then adapt to the payer context described here.
Supporting submissions to NICE, CADTH, ICER, G-BA, and HAS
Different agencies ask for evidence in different shapes, and a well-built review anticipates those shapes from the protocol stage. For NICE in England, the emphasis falls on a transparent clinical systematic literature review feeding a de novo cost-effectiveness model aligned to the reference case set out in the NICE health technology evaluations methods guide, with clear handling of comparators in the final scope. The exact shape of the evidence requirement varies depending on the target agency. For CADTH in Canada, reviewers expect rigorous systematic methods and often a companion economic review. ICER in the United States frames value around long-term outcomes and budget impact, so the evidence base must speak to both, and any budget impact models are constructed in line with the ISPOR budget impact analysis good practice II report (Sullivan et al., Value in Health, 2014). The G-BA process in Germany, assessed by IQWiG, sets a high bar for methodological rigour, with strict rules on evidence hierarchy and comparator relevance. HAS in France weighs both clinical benefit and its added value relative to existing options.
A single global programme rarely satisfies all of these at once without deliberate design. We build the clinical systematic literature review as the master evidence layer, then structure jurisdiction-specific outputs from it so that one protocol supports many submissions. This is where regulatory-grade evidence discipline matters, and our pharmaceutical and regulatory evidence support team works alongside methodology to keep the review aligned with the dossier narrative rather than divorced from it.
Three synthesis layers: clinical, economic, and humanistic
Most value dossiers rest on three complementary reviews, and treating them as one undifferentiated search is a common and costly mistake.
Clinical systematic literature reviews
The clinical review establishes comparative efficacy and safety. It captures the randomised and, where relevant, non-randomised evidence for the intervention and its comparators, extracts outcomes consistently, and feeds both the value story and any quantitative comparison. This layer must be defensible because it anchors the entire submission.
Economic systematic literature reviews
An economic systematic literature review identifies published cost-effectiveness analyses, cost-utility analyses, cost studies, and utility or health-state valuation data. Its purpose is to inform model structure, populate parameters, and demonstrate that the cost-effectiveness and cost-utility models are grounded in the existing literature rather than assembled ad hoc. The synthesis follows the reporting and conduct standards a health economist expects, including the CHEERS 2022 reporting standard for economic evaluations (Husereau et al., BMJ, 2022) and the framework set out in Methods for the Economic Evaluation of Health Care Programmes, 4th edition (Drummond et al., 2015), alongside the ISPOR Good Research Practices Task Force reports. A cost-effectiveness review done well saves modelling time and pre-empts payer challenges about parameter provenance.
Humanistic and patient-reported-outcome reviews
A humanistic or patient-reported-outcome review synthesises health-related quality of life, treatment burden, and patient preference evidence. As payers weigh patient-centred value more heavily, this layer increasingly influences appraisal outcomes and pricing arguments.
Because these three layers share a screening backbone but diverge in extraction and appraisal, we scope them together and cost them transparently. When quantitative pooling is needed, our done-for-you meta-analysis handles the statistical synthesis that sits on top of the clinical layer.
PICOS scoping and the search strategy that follows
Nothing in a payer review matters more than getting the PICOS frame right, because it governs the search, the inclusion criteria, and ultimately the credibility of the whole submission. A frame drawn too narrowly misses relevant comparators and invites a rejection for incomplete evidence; drawn too broadly, it buries reviewers in irrelevant records and inflates cost. We fix the population, intervention, comparators, outcomes, and study designs against the anticipated appraisal scope, then translate that frame into a reproducible search.
A defensible market access literature review searches beyond a single database. We cover MEDLINE and Embase as standard, add the Cochrane Library for trials and reviews, and include economic and HTA-specific sources such as the databases maintained by HTA agencies and the grey literature that payers know to look for. Conference abstracts and trial registries are searched to reduce reporting bias, which agencies specifically probe. The search strings, database coverage, and dates are all documented so the review can be re-run and audited. Teams that want the search built and peer-reviewed as a standalone deliverable can commission our literature search strategy service and hand the validated strings to their internal analysts.
Head-to-head trials against every relevant comparator rarely exist, yet payers still need comparative effectiveness. This is where indirect treatment comparison and network meta-analysis become central to the submission.
When trials share a common comparator, a Bucher indirect treatment comparison or a Bayesian network meta-analysis can estimate relative effects across a connected evidence network. When populations differ enough that simple anchored comparisons are biased, population-adjusted methods such as matching-adjusted indirect comparison and simulated treatment comparison come into play. Choosing the right method is a methodological judgement, not a default, and it depends on network geometry, effect-measure consistency, and the availability of individual patient data.
We assess network feasibility before promising a pooled estimate, test the homogeneity and consistency assumptions that agencies scrutinise, and report uncertainty honestly. Our evidence synthesis service coordinates the review and the comparison so the network is built from the same locked evidence base as the clinical review, and our biostatistics team runs the Bayesian models and sensitivity analyses that underpin a credible comparative-effectiveness claim.
Not every market access question warrants a full systematic review, and pretending otherwise wastes budget and time. A targeted literature review applies a focused, transparent, but pragmatically bounded search to answer a narrower question quickly, for example an early landscape scan, a feasibility check before committing to a full programme, or an update of a specific parameter. A full systematic literature review applies the complete, protocol-driven, exhaustive process required when the output must anchor a formal submission.
The right choice depends on the decision at stake, the deadline, and the level of scrutiny the output will face. We recommend a targeted literature review for exploratory and internal decisions and reserve the full systematic literature review for submission-grade deliverables, and we say so plainly at scoping rather than overselling the larger engagement. Where a targeted review later needs to become a full review, we design the earlier work so it can be extended rather than repeated.
Reporting, quality appraisal, and guidance alignment
A payer-facing review earns trust through its methods documentation. We report to the PRISMA 2020 Statement (Page et al., BMJ, 2021), including the flow diagram and item-level checklist that agencies expect. Critical appraisal uses AMSTAR 2 for reviews and validated risk-of-bias instruments for the underlying studies, including the Cochrane Risk of Bias 2 tool for randomised trials and ROBINS-I for non-randomised studies. Where certainty of evidence must be graded, we apply GRADE.
The methodological backbone follows the Cochrane Handbook for systematic review conduct and the guidance from the Centre for Reviews and Dissemination, which agencies recognise as authoritative for reviews that inform decision-making. Aligning to these references is not box-ticking; it is what lets a payer methods team accept the review without re-doing it. Every appraisal judgement is recorded with its rationale so the audit trail is complete.
The output is built to slot directly into your submission architecture. Typical deliverables span the systematic literature review of clinical and economic evidence, the locked protocol, the reproducible search documentation, the PRISMA flow diagram, the full extraction tables, the appraisal ratings, the narrative synthesis, and, where relevant, indirect and mixed treatment comparison, cost-effectiveness and cost-utility models, budget impact models, value dossiers, and submission-ready evidence together with the sensitivity analyses that support them. These components populate the clinical and economic sections of a global value dossier or an Academy of Managed Care Pharmacy (AMCP dossier), and map cleanly to the clinical and cost-effectiveness chapters of an HTA submission.
We provide the review in formats your writers and modellers can use, including structured extraction files rather than static tables alone, so parameters flow into the economic model without manual re-keying. The aim is a coherent evidence layer that your dossier team, your modellers, and your regulatory writers all draw from the same source.
Confidentiality, purchase orders, and named methodologist
Institutional work runs on written terms. Engagements proceed under a defined scope of work with a named methodologist, in this case Dr. Kwame Asante (PhD Health Systems) leading review methodology. We work under non-disclosure agreements as standard for pre-launch and commercially sensitive programmes, accept purchase orders from manufacturers, consultancies, and health economics and outcomes research teams, and keep unpublished data and pipeline details strictly confidential. We provide methodological and evidence-synthesis support; we do not guarantee reimbursement or regulatory approval.
Whether you are a manufacturer preparing a first submission, a consultancy delivering to a client, or an in-house health economics and outcomes research function scaling review capacity, we structure the engagement around your deadlines and your governance requirements. Each engagement is matched with a health economist or methodologist experienced with your target agency and therapy area, so the review speaks the language of the assessors at NICE, CADTH, IQWiG, and other HTA agencies, and the payers behind them. You can review our ask to see published deliverables to see the standard of documentation these assessors receive. To begin, share the indication, the target agencies, and the timeline through a scoped quote request, and we will map the right combination of clinical, economic, and humanistic reviews to your submission as a fixed fee agreed before work starts.
Real-world evidence and patient-reported outcomes
Our HTA and market-access work extends to real-world evidence studies, drawing on claims and electronic health record data, and to patient-reported outcomes analysis, including quality-of-life instruments and utility mapping for economic models. Whether you need a real-world evidence feasibility review, a patient-reported outcomes evidence synthesis, or the clinical inputs for a cost-effectiveness or budget-impact model, the evidence is assembled to the standard assessment bodies expect.